Senior Quality Assurance Specialist

Job Details: Title: Sterilization Specialist Senior EngineerDuration: 12 Months ContractLocation: Cambridge, MATax Term: W2Job Diva Id: 25-32249 (Client's Id pending)Ideally looking for someone locally but open to someone who will relocate with the proper and strong sterilization experienceJob DescriptionThe Senior Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for Client's portfolio of therapeutic products from concept through commercial entry. The individual advances technical programs, contributing to definition of design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. The successful candidate establishes well-supported insights for development, clinical and commercial stage solutions to serve user needs and the needs of the pipeline portfolio, using a range of program tools, design characterization and verification methods, and design reviews. She ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.Top Must Have Skill Sets:Sterilization experienceQualification quality experienceCommercial process lifecycle managementResponsibilities include but are not limited to:Support lead process development and commercialization of gas sterilization processes of combination productsCoordinate lead manufacturing site requirements to support sterilization requirementsSupport the design control process and qualification of primary componentsSupport lead tech transfer projects for combination productsSupport lead the development and operational improvements with key primary component suppliersSupport development of characterization methods for mechanical and physical properties of primary componentsSupport on-going deviation CAPA and change controlSupport lead Client supplier raw materials sterility assurance assessmentsCollaborate extensively with internal and external stakeholders i.e. manufacturing, suppliers, quality, regulatory, senior management, etc.Drive and influence key opinion leaders by providing technical papers, presentations and attending key conferencesPreferred Qualifications:3+ years in ethylene oxide or other gas sterilization processes3+ years industry experience in sterility assurance of combination products3+ years in ethylene oxide, moist heat, and or vaporized hydrogen peroxide sterilizationAbility to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulationsStrong problem-solving skillsCapability to advance multiple projects in a fast paced environmentStrong oral and written communication skills, decision making, presentation, and organization skills

Created: 2025-02-22